Closing instrument for realizing puncture through tissue limitation

Abstract

The invention relates to the field of medical instruments, in particular to a closing instrument for achieving puncture through tissue limitation, the closing instrument is used for closing a channel between first tissue and second tissue and comprises a supporting unit, an abutting unit, a puncture unit and an auxiliary positioning unit, and the auxiliary positioning unit comprises a positioning piece and a control piece connected with the positioning piece; the control piece is connected with the far-end part of the abutting unit; the abutting unit, the supporting unit and the auxiliary positioning unit are combined to limit the relative position of the first tissue between the control piece and the supporting unit.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and particularly to a closure device for piercing through restricted tissue. Background Art

[0002] The foramen ovale is a physiological passage in the atrial septum of the heart during embryonic development. Since the fetus does not have pulmonary circulation, oxygenated blood from the umbilical cord flows from the right atrium of the fetus through the foramen ovale into the left atrium. After birth, with the establishment of pulmonary circulation, the pressure in the left atrium increases, and the secondary septum and the primary septum approach, adhere and fuse with each other, gradually forming a permanent atrial septum. However, in some people, the foramen ovale remains unfused, resulting in patent foramen ovale (abbreviated as PFO). In the past, patent foramen ovale (PFO) was mostly considered a benign variation without harm. With recent clinical studies, experts have reached a consensus that patent foramen ovale (PFO) is one of the causes of cryptogenic stroke, migraine, paradoxical embolism, etc. Therefore, PFO occlusion or closure is required. Treatment methods for PFO closure include implanting a occluder disk or suturing the unclosed passage. Since a relatively large piece of indigestible device will remain in the heart after the occluder disk is implanted, it is not conducive to the patient's recovery and will also affect other surgical treatments. Clinically, the suture method is often recommended.

[0003] The existing suture methods for PFO channels are generally as follows: 1. By using a curved needle to puncture the secondary septum tissue and the primary septum tissue, the suture passing through the primary septum tissue will be pulled in the direction of the secondary septum when being pulled. Such an operation does not conform to the physiological structure of the primary septum and will also cause the hole in the primary septum tissue to become larger, resulting in secondary injury; 2. At least two puncture needles are used to sequentially puncture the secondary septum tissue and the primary septum tissue. This method requires a support structure to be set on the left atrial surface. Otherwise, it is difficult to determine the puncture position, and the puncture success rate is also low. Moreover, this method also requires knotting two sutures on the right atrial surface, with many operation steps, a long operation time, a large diameter of the delivery tube, and great harm to the human body.

[0004] In summary, the following problems that need to be urgently solved exist in the prior art: First, at least two puncture actions are required in the prior art, with many operation steps; Second, the positions of the secondary septum or the primary septum tissue are not fixed during puncture, making puncture inconvenient; Third, it is difficult to control the position and stability of the abutting point, making it inconvenient to perform puncture at an ideal position. Summary of the Invention

[0005] In view of the above and other more ideas, the present application is proposed.

[0006] One of the purposes of the present application is to overcome the deficiencies of the prior art. In view of the problems in the prior art such as multiple actions of the puncture instrument during tissue puncture, flexible and unfixed puncture targets, and limited selection of abutting positions, a closure device for piercing through restricted tissue is provided.

[0007] The object of the present invention is achieved by the following solutions: A closing device for restricting tissue to achieve puncture, used to close the passage between a first tissue and a second tissue, comprising a support unit, an abutting unit, a puncturing unit, and an auxiliary positioning unit. The auxiliary positioning unit includes a positioning member and a control member connected to the positioning member, and the control member is connected to the distal portion of the abutting unit; the relative position of the first tissue between the control member and the support unit is jointly restricted by the abutting unit, the support unit, and the auxiliary positioning unit.

[0008] The object of the present invention can also be further achieved by the following technical solutions: In one embodiment, it further includes an auxiliary abutting mechanism. By operating the auxiliary abutting mechanism, the included angle formed between the control member and the support unit is reduced, and the clamping force on the first tissue is increased to stabilize the needle insertion positioning of the puncturing unit in the first tissue and ensure the continuous progress of the needle insertion process.

[0009] In one embodiment, the auxiliary abutting mechanism includes a delivery tube sleeved outside the closing device, and the abutting unit is pre-installed in the delivery tube.

[0010] In one embodiment, the abutting unit includes a moving part and a deforming part provided at the distal end. A limiting structure is provided at the distal end of the delivery tube, and the limiting structure provides a supporting force at the proximal end of the deforming part.

[0011] In one embodiment, the positioning member is a tubular member, and all or the proximal part of the support unit can penetrate through the lumen of the positioning member and achieve relative movement with the positioning member; moreover, after release, the support unit fits the channel surface of the second tissue.

[0012] In one embodiment, the positioning member is a positioning core.

[0013] In one embodiment, the positioning member is an elongated metal wire.

[0014] In one embodiment, the puncturing unit is pre-installed in the abutting unit; and when the puncturing unit punctures, it directly passes through the first tissue and the second tissue unidirectionally.

[0015] In one embodiment, the overlapping area of the first tissue and the second tissue is the puncturing area of the puncturing needle.

[0016] In one embodiment, the control member passes through the through hole on the positioning member or is connected to the abutting unit at the distal end of the positioning member.

[0017] In one embodiment, the proximal end of the control member is actively controlled, and the proximal end of the control member is pulled to change the position where the distal end of the abutting unit fits against the first tissue.

[0018] In one embodiment, the support unit includes a first support portion and a second support portion, which are an integral body, and the first support portion and the second support portion respectively fit against the channel surface of the first tissue and the channel surface of the second tissue.

[0019] In one embodiment, the first support portion includes a plurality of first support members arranged in a divergent manner, and the second support portion includes a plurality of second support members with bent distal portions.

[0020] In one embodiment, the abutting unit is connected to a bending control mechanism. By operating the bending control mechanism, the distal end of the abutting unit rotates and / or swings towards the support unit until the distal end of the abutting unit abuts against the proximal end surface of the first tissue, and the center line of the distal end of the abutting unit is perpendicular to or forms an obtuse angle with the surface of the first support portion.

[0021] In one embodiment, the angle formed by the center line of the distal end of the abutting unit and the surface of the first support portion is the angle formed by the abutting direction of the abutting unit and the distal direction of the first support portion.

[0022] In one embodiment, when the center line of the distal end of the abutting unit forms an obtuse angle with the surface of the first support portion, the puncture point of the puncture unit on the primary septum is lower, and the puncture point will be in the middle area of the primary septum, and the closing effect is good.

[0023] In one embodiment, the first tissue is the tissue of the secondary septum, and the second tissue is the tissue of the primary septum.

[0024] In one embodiment, after the distal end of the deformable portion contacts the tissue of the secondary septum, the moving portion is further pushed so that the deformable portion abuts against the wall of the right atrium to maintain the position of the deformable portion.

[0025] In one embodiment, the abutting unit is manipulated or the moving portion is pushed to form a deformed and bent transition state of the deformable portion in the right atrium cavity, and the moving portion is further pushed so that the distal end of the deformable portion contacts the tissue of the secondary septum.

[0026] In one embodiment, the control member is linear, filamentous or cord-like, and the abutting unit includes a connecting portion connected to the control member; and when the abutting unit is pushed to move distally, the connecting portion moves to the proximal end surface of the first tissue along with the control member.

[0027] In one embodiment, a visualization member is further provided on the connecting portion.

[0028] In one embodiment, the support unit is released prior to the abutment unit.

[0029] In one embodiment, after the support unit is released, the support unit conforms to the first tissue and / or the second tissue.

[0030] In one embodiment, the support unit conforms to at least the second tissue.

[0031] In one embodiment, the auxiliary positioning unit is connected to the support unit and the abutment unit.

[0032] In one embodiment, the positioning member and the control member are fixedly connected or movably connected.

[0033] In one embodiment, the puncturing unit is pre-mounted in the abutment unit; and when the puncturing unit punctures, it directly passes through the first tissue, the support unit, and the second tissue in sequence.

[0034] In one embodiment, when the puncturing unit punctures, it directly passes through the first tissue and the second tissue in sequence.

[0035] In one embodiment, when the puncturing unit punctures, both the first tissue and the second tissue are restricted by the support unit and no longer move.

[0036] In one embodiment, the puncturing unit includes a puncturing needle and a locking member pre-mounted in the puncturing needle.

[0037] In one embodiment, the puncturing unit includes at least one puncturing needle.

[0038] In one embodiment, the locking member includes a limiting head and a connecting line, and the limiting head forms an angle with the connecting line after separating from the puncturing needle.

[0039] In one embodiment, the control member passes through a through hole in the positioning member and is connected to the abutment unit; and the proximal end of the control member is for active control, and pulling the proximal end of the control member changes the position where the distal end of the abutment unit abuts against the first tissue.

[0040] In one embodiment, the positioning member includes two through holes.

[0041] In one embodiment, the through hole is at a certain distance from the end of the positioning member.

[0042] In one embodiment, at least the distal part of the positioning member is located in the channel between the first tissue and the second tissue when the puncturing unit punctures.

[0043] In one embodiment, the channel surface of the first tissue is the distal end surface that coincides with the second tissue region.

[0044] In one embodiment, the channel surface of the second tissue is the proximal end surface that coincides with the first tissue region.

[0045] In one embodiment, the support unit is in the shape of a bracket.

[0046] In one embodiment, the support unit is in the shape of a long rod.

[0047] In one embodiment, the first support portion includes four of the first support members.

[0048] In one embodiment, the second support portion includes four of the second support members.

[0049] In one embodiment, the abutting unit has flexibility. When the abutting unit abuts against the proximal end surface of the first tissue, the center line of the distal end of the abutting unit is perpendicular to the surface of the first support portion.

[0050] In one embodiment, the abutting unit is an abutting tube, and the abutting tube is a tube made of an elastic polymer material.

[0051] In one embodiment, the length of the control member exposed in the right atrium is a first length, and the size of the first length can be controlled by the operator, thereby affecting the fitting position of the abutting unit and the first tissue.

[0052] In one embodiment, the bending portion is subjected to the pulling force of the control member, the supporting force of the right atrium, and the supporting force of the limiting structure. The acting forces at these three places keep the deforming portion stable, so that the abutting unit remains stationary when the puncturing unit punctures.

[0053] In one embodiment, the operator determines the abutting point of the abutting unit on the right atrial surface by observing the position of the imaging member.

[0054] In one embodiment, after releasing the support unit, the support unit fits with the second tissue. More specifically, the second support portion fits with the second tissue. After releasing the abutting unit, it moves distally. The abutting unit pushes the first tissue to move distally until the first tissue fits with the first support portion. At this time, both the distal end and the proximal end of the first tissue are restricted, and the center line of the distal end of the abutting unit is perpendicular to the surface of the first support portion.

[0055] In one embodiment, after the support unit is released, the support unit is attached to the first unit and the second tissue. More specifically, the second support portion is attached to the second tissue, and the first support portion is attached to the first tissue.

[0056] In one embodiment, when the puncture needle is puncturing, the puncture needle is perpendicular to the first supporting portion, and the puncture needle is at a certain angle to the second supporting portion.

[0057] In one embodiment, during the puncture needle performing the puncture action, the positioning member remains stationary.

[0058] Compared with the prior art, the advantages of the technical solution of the present application include at least the following: 1. Existing closure devices usually require two operating steps to leave puncture points on both the primary septum tissue and the secondary septum tissue, which makes the operation complicated and time-consuming. In addition, since the foramen ovale tissue is active during puncture, it is difficult to guarantee the success rate. At the same time, the abutment action before puncture is also difficult to guarantee. For example, where the abutment tube is located on the right atrial surface, the abutment tube shakes when the puncture needle moves, affecting the puncture position. The present application solves the above problems. First, the present application adopts a method of directly penetrating the primary septum and the secondary septum. In order to ensure that a puncture action can be achieved (no need to puncture back and puncture twice respectively), a support unit is used to fit the second tissue. At this time, the first tissue is also fit by the support unit. Even if it is not fit, the abutment unit will push the first tissue toward the support unit after reaching the proximal surface of the first tissue, thereby ensuring that the first tissue is restricted by the abutment unit and the support unit, laying a good foundation for the puncture action of "the target tissue does not move", so that the puncture unit can be punctured once in one direction. It can pass through two tissues without adjusting the puncture direction during the puncture process; on the other hand, the control part of the present application is connected to the distal part of the abutment unit. Pulling the control part can ensure that the abutment unit is subjected to a pulling force in the proximal direction, and can also adjust the relative position of the abutment unit and the first tissue, that is, changing the axial distance between the distal end of the abutment unit and the positioning part, and continuously pushing the abutment unit can enable the abutment unit to obtain the support force of the right atrium wall, ensuring that the abutment unit will not shake excessively when the puncture needle moves; finally, since the distal end of the abutment unit pushes the first tissue, the distal end of the first tissue is supported by the supporting unit, so that there is a force balance between the abutment unit and the supporting unit. Therefore, the distal end of the abutment unit is perpendicular to the part of the supporting unit, which is very beneficial for the puncture needle to perform the puncture action on the first tissue. In summary, the closing device of the present application is not only convenient for puncture, but also can ensure the puncture position of the first tissue, and the action is simple, which can effectively reduce the operation time and has great promotion significance.

[0059] 2. Different from the prior art, the first tissue is the primary septum, and the second tissue is the secondary septum. The overlapping area of the two is the puncture area of the puncture needle and also the abutment area of the abutment unit (abutment tube). The operator can determine the abutment area by observing the imaging structure of the connection part and the position of the second support part. If the abutment unit exceeds the abutment area, the control member can be pulled to drive the abutment unit to move back to the abutment area. The setting of the control member can ensure that the proximal end of the abutment unit reaches the target position of the right atrium of the foramen ovale.

[0060] 3. Different from the prior art, the support unit of the present application includes a first support part and a second support part. The two are an integral whole and have shape memory. After release, the first support member and the second support member will move towards the secondary septum tissue and the primary septum tissue respectively, with good support effect. At the same time, the bending setting of the distal part of the second support member can limit the movement of the primary septum tissue towards the distal end, ensuring the fitting state of the primary septum.

[0061] 4. Different from the prior art, during the movement of the puncture needle towards the distal end, the puncture needle will exert a force on the large bend side of the abutment tube. To ensure that the abutment unit maintains the abutment state, the distal end of the abutment tube receives the pulling force of the control member, the middle part of the abutment tube receives the supporting force of the right atrial wall, and the proximal part of the abutment tube receives the supporting force from the limiting structure. The three positions correspond to the force of the puncture needle at the same time, thereby ensuring the position stability of the abutment tube.

[0062] 5. Different from the prior art, the present application further includes an auxiliary abutment mechanism, which can provide a supporting force for the deformation part of the abutment unit and can also be used to adjust the angle between the control member and the support unit. The smaller the angle between the two, the greater the clamping force on the secondary septum, the more stable the state of the secondary septum is maintained, and the smoother the puncture of the secondary septum is.

[0063] The embodiments of the present application can achieve other beneficial technical effects that are not listed one by one. Some of these other technical effects may be described below; and for those skilled in the art, they can be expected and understood after reading the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0064] By referring to the following description in conjunction with the drawings, the above-mentioned features and advantages of these embodiments and other features and advantages and the manner of achieving them will become more obvious; and the embodiments of the present application can be better understood. In the drawings: Figure 1 and Figure 2 is a schematic diagram of the overall structure of the closing device of the present invention.

[0065] Figure 3 is a schematic diagram of the structure of the puncture unit of the present invention.

[0066] Figure 4Schematic diagram of the relationship between the closing device of the present invention and the right atrium.

[0067] Figures 5 to 11 Schematic diagram of the operation process of the present invention.

[0068] Figure 12 Schematic diagram of another embodiment of the present invention.

[0069] Figure 13 and Figure 14 Schematic diagram of another embodiment of the present invention.

[0070] The features referred to by each number in the drawings are as follows: 1 - First tissue, 2 - Second tissue, 3 - Support unit, 31 - First support part, 311 - First support member, 32 - Second support part, 321 - Second support member, 4 - Abutting unit, 41 - Abutting tube, 42 - Deformation part, 43 - Moving part, 44 - Connecting part, 441 - Visualization member, 5 - Puncturing unit, 51 - Puncturing needle, 52 - Locking member, 521 - Limiting head, 522 - Connecting line, 6 - Auxiliary positioning unit, 61 - Positioning member, 611 - Through hole, 62 - Control member, 7 - Outer sheath tube, 8 - Auxiliary abutting structure, 81 - Delivery tube, 811 - Limiting structure, 9 - Bending control mechanism. Detailed implementation manners

[0071] In the following descriptions of the drawings and detailed implementation manners, details of one or more embodiments of the present application will be elaborated. From these descriptions, drawings, and claims, other features, objectives, and advantages of the present application can be clearly understood.

[0072] It should be understood that the phrases and terms used herein are for the purpose of description and should not be considered restrictive. The use of "including", "comprising", or "having" and their variants herein is intended to include the items listed thereafter, their equivalents, and additional items in an open - ended manner.

[0073] The present application will be described in more detail below with reference to different embodiments and examples of several aspects of the present application.

[0074] In the present application, the term "proximal" or "proximal side" refers to the end or side closer to the surgical operator, and "distal" or "distal side" refers to the end or side farther from the surgical operator.

[0075] In the prior art, there are problems that the puncturing instrument does not provide support for the secondary septal tissue and it is difficult to control the puncturing point.

[0076] One of the objectives of the following - described embodiments is to address the above - mentioned defects and other problems. Embodiment 1

[0077] AsFigure 1 and 2 As shown, when the solution of the present invention is used to close the tissue of the patent foramen ovale, a closing device for piercing by restricting tissue according to an embodiment of the present application is illustrated, which is used to close the channel between the first tissue 1 and the second tissue 2, and includes a support unit 3, an abutting unit 4, a puncturing unit 5 and an auxiliary positioning unit 6. The auxiliary positioning unit 6 includes a positioning member 61 and a control member 62 connected to the positioning member. The control member 62 is connected to the distal portion of the abutting unit 4; the abutting unit 4, the support unit 3 and the auxiliary positioning unit 6 jointly restrict the relative position of the first tissue 1 between the control member 62 and the support unit 3.

[0078] In the first embodiment, an auxiliary abutting mechanism 8 is further included. The auxiliary abutting mechanism 8 includes a delivery tube 81. By operating the delivery tube 81, the included angle formed between the control member 62 and the support unit 3 is reduced, the control member 62 swings towards the support unit 3, and the clamping force on the first tissue 1 increases, so as to stabilize the needle insertion positioning of the puncturing unit 5 in the first tissue 1 and ensure the continuous progress of the needle insertion process, as Figure 7 and Figure 8 shown.

[0079] In the first embodiment, the abutting unit 4 is pre-installed in the delivery tube 81.

[0080] In the first embodiment, the positioning member 61 is a tubular member, and all or the proximal portion of the support unit 3 can penetrate through the lumen of the positioning member 61 and realize relative movement with the positioning member 61.

[0081] In the first embodiment, the auxiliary positioning unit 6 includes a positioning member 61 and a control member 62 connected to the positioning member 61. The support unit 3 is pre-installed in the positioning member 61. The abutting unit 4 and the support unit 3 restrict the first tissue 1, and the support unit 3 fits the channel surface of the second tissue 2.

[0082] In the first embodiment, the auxiliary positioning unit 6 is connected to the support unit 3 and the abutting unit 4.

[0083] In the first embodiment, the positioning member 61 and the control member 62 are movably connected.

[0084] In the first embodiment, the puncturing unit 5 is pre-installed in the abutting unit 4; and when the puncturing unit 5 punctures, it directly passes through the first tissue 1, the support unit 3 and the second tissue 2 in sequence, as Figure 9 shown.

[0085] In the first embodiment, the puncturing unit 5 includes a puncturing needle 51 and a locking member 52 pre-installed in the puncturing needle 51. As Figure 3 shown, the overlapping area of the first tissue 1 and the second tissue 2 is the puncturing area of the puncturing needle 51.

[0086] In the first embodiment, the locking member 52 includes a limiting head 521 and a connecting line 522. After the limiting head 521 detaches from the puncturing needle 51, it forms a certain angle with the connecting line 522, and the limiting head 521 fits against the distal end surface of the second tissue 2.

[0087] In the first embodiment, the control member 62 passes through the through hole 611 on the positioning member 61 and is connected to the abutting unit 4. The positioning member 61 includes two through holes 611; moreover, the proximal end of the control member 62 is for active control. By pulling the proximal end of the control member 62, the position where the distal end of the abutting unit 4 fits against the first tissue 1 is changed, as Figure 7 and Figure 8 shown.

[0088] In the first embodiment, the through hole 611 has a certain distance from the end of the positioning member 61, and at least the distal part of the positioning member 61 is located in the channel between the first tissue 1 and the second tissue 2 when the puncturing unit 5 punctures.

[0089] In the first embodiment, the supporting unit 3 includes a first supporting part 31 and a second supporting part 32, which are an integral whole, and they respectively fit against the channel surfaces of the first tissue 1 and the second tissue 2.

[0090] In the first embodiment, the first supporting part 31 includes a plurality of first supporting members 311 arranged in a divergent shape, and the second supporting part 32 includes a plurality of second supporting members 321 with bent distal parts, as Figure 1 shown.

[0091] In the first embodiment, the supporting unit 3 is in the shape of a bracket.

[0092] In the first embodiment, the first supporting part 31 includes four of the first supporting members 311, and the second supporting part 32 includes four of the second supporting members 321.

[0093] In the first embodiment, the abutting unit 4 has flexibility. When the abutting unit 4 is about to closely adhere to the proximal end surface of the first tissue 1, the center line of the distal end of the abutting unit 4 is perpendicular to the surface of the first supporting part 31.

[0094] In the first embodiment, the abutting unit 4 is an abutting tube 41, and the abutting tube 41 is a tube made of an elastic polymer material.

[0095] In the first embodiment, the abutting unit 4 includes a moving part 43 and a deforming part 42 arranged at the distal end, as Figure 2 shown; the first tissue 1 is the secondary septal tissue, and the second tissue 2 is the primary septal tissue, as Figure 5 shown. After the distal end of the deforming part 42 contacts the secondary septal tissue, the moving part 43 is continuously pushed, so that the deforming part 42 abuts against the wall of the right atrium to maintain the position of the deforming part 42, as Figure 4 shown.

[0096] In the first embodiment, the length of the control member 62 exposed in the right atrium is a first length, and the size of the first length can be controlled by the operator, thereby affecting the fitting position of the abutting unit 4 and the first tissue 1.

[0097] In the first embodiment, it further includes an outer sheath tube 7 and a delivery tube 81. The abutting unit 4 is pre-installed in the delivery tube 81, and both the delivery tube 81 and the positioning member 61 are pre-installed in the outer sheath tube 7, as Figure 2 shown.

[0098] In the first embodiment, the control member 62 is in a linear, filamentous or cord-like shape, and the abutting unit 4 includes a connecting part 44 connected to the control member 62; moreover, when pushing the abutting unit 4 to move distally, the connecting part 44 swings with the control member 62 to the proximal end face of the first tissue 1.

[0099] In the first embodiment, a developing member 441 is further arranged on the connecting part 44, and the operator judges the abutting point of the abutting unit 4 on the right atrial surface by observing the position of the developing member 441.

[0100] In the first embodiment, the supporting unit 3 is released prior to the abutting unit 4; and after the supporting unit 3 is released, the supporting unit 3 fits with the first tissue 1 and the second tissue 2.

[0101] In the first embodiment, after the supporting unit 3 is released, the supporting unit 3 fits with the first unit and the second tissue 2. More specifically, the second supporting part 32 fits with the second tissue 2, and the first supporting part 31 fits with the first tissue 1.

[0102] In the first embodiment, when the puncture needle 51 punctures, the puncture needle 51 is perpendicular to the first supporting part 31, and the puncture needle 51 forms a certain angle with the second supporting part 32.

[0103] The exemplary operation process of the closure device in the first embodiment is as follows: (1) Establish a PFO access channel, reserve a guide wire, ensure that the distal end of the guide wire is in the left atrium position, and then insert the outer sheath tube 7 into the right atrium through the transfemoral venous access along the guide wire, and then push it to the position of the unclosed channel between the secondary septum and the primary septum close to the atrial septum; (2) Retract the outer sheath tube 7 so that the positioning member 61 is located in the channel, and then retract the positioning member 61 to release the support unit 3, and release the support unit 3 to fit with the secondary septum and the primary septum, as Figure 5 and Figure 6 shown; (3) Retract the delivery tube 81 to release the abutment tube 41, push the moving part 43 to cause the deformation part 42 to bend, pull the control member 62 so that the distal end of the abutment tube 41 reaches the target position, and continue to push the moving part 43. The middle part of the abutment unit 4 abuts against the wall surface of the right atrium, as Figure 4 and Figure 7 shown. At this time, the abutment tube 41 cooperates with the first support part 31 to clamp the secondary septum tissue, and the abutment tube 41 is perpendicular to the first support part 31, as Figure 8 shown; (4) Operate the puncture unit 5 to move distally. The puncture needle 51 directly penetrates the secondary septum and the primary septum, release the locking member 52, and withdraw the puncture needle 51, as Figure 9 and Figure 10 shown; (5) Tighten the connection line 522, and operate and complete the locking of the connection line 522 in the right atrium, as Figure 11 shown. Embodiment 2

[0104] Embodiment 2 is substantially the same as Embodiment 1, except that a limiting structure 811 is provided at the distal end of the delivery tube 81 in this embodiment, as Figure 12 shown.

[0105] In this embodiment, a closing device for realizing puncture through restricted tissue is disclosed, which is used to close the channel between the first tissue 1 and the second tissue 2, and includes a support unit 3, an abutment unit 4, a puncture unit 5 and an auxiliary positioning unit 6. The auxiliary positioning unit 6 includes a positioning member 61 and a control member 62 connected to the positioning member. The control member 62 is connected to the distal part of the abutment unit 4; the abutment unit 4, the support unit 3 and the auxiliary positioning unit 6 jointly limit the relative position of the first tissue 1 between the control member 62 and the support unit 3.

[0106] In Embodiment 2, a limiting structure 811 is provided at the distal end of the delivery tube 81, and the limiting structure 811 provides a supporting force at the proximal end of the deformation part 42.

[0107] In the second embodiment, the bending part is subjected to the pulling force of the control member 62, the supporting force of the right atrium, and the supporting force of the limiting structure 811. The acting forces at these three locations keep the deforming part 42 stable, so that the abutting unit 4 remains stationary when the puncturing unit 5 performs puncturing.

[0108] In the second embodiment, after the supporting unit 3 is released, the supporting unit 3 fits with the second tissue 2. More specifically, the second supporting part 32 fits with the second tissue 2. The abutting unit 4 is released and moves distally. The abutting unit 4 pushes the first tissue 1 to move distally until the first tissue 1 fits with the first supporting part 31. At this time, both the distal end and the proximal end of the first tissue 1 are restricted, and the center line of the distal end of the abutting unit 4 is perpendicular to the surface of the first supporting part 31.

[0109] In the second embodiment, the limiting structure 811 is arranged on the large bending side of the deforming part 42 of the delivery tube 81.

[0110] In the second embodiment, the limiting structure 811 is fan-shaped and functions to protect and limit the abutting unit 4.

[0111] In this regard, the related structures and concepts of the second embodiment are similar to those of the first embodiment, so they will not be repeated here. Embodiment Three

[0112] As Figure 13 and Figure 14 shown, when the solution of the present invention is used to close the foramen ovale tissue, a closing instrument for realizing puncture through restricted tissue according to an embodiment of the present application is illustrated. It is used to close the channel between the first tissue 1 and the second tissue 2, and includes a supporting unit 3, an abutting unit 4, a puncturing unit 5, and an auxiliary positioning unit 6. The auxiliary positioning unit 6 includes a positioning member 61 and a control member 62 connected to the positioning member. The control member 62 is connected to the distal part of the abutting unit 4; the abutting unit 4, the supporting unit 3, and the auxiliary positioning unit 6 jointly restrict the relative position of the first tissue 1 between the control member 62 and the supporting unit 3.

[0113] In the third embodiment, the supporting unit 3 is a metal wire-like member, and the positioning member 61 enters the lesion along the supporting unit 3.

[0114] In the third embodiment, the whole of the supporting unit 3 passes through the lumen of the positioning member 61.

[0115] In the third embodiment, the control member 62 passes through the distal end of the positioning member 61 and is connected to the abutting unit 4; and, the proximal end of the control member 62 is for active control, and pulling the proximal end of the control member 62 changes the position where the distal end of the abutting unit 4 fits against the first tissue.

[0116] In the third embodiment, the abutting unit 4 is connected to the bending control mechanism 9. By operating the bending control mechanism 9, the distal end of the abutting unit 4 rotates and / or swings towards the support unit until the distal end of the abutting unit 4 abuts against the proximal end surface of the first tissue 1, and the center line of the distal end of the abutting unit 4 is perpendicular to or forms an obtuse angle with the surface of the support unit 3, as Figure 13 and Figure 14 shown.

[0117] In the third embodiment, the abutting unit 4 is manipulated or the moving part 43 is pushed, so that the deforming part 42 forms a deformed and bent transition state in the right atrium cavity, and by continuously pushing the moving part 43, the distal end of the deforming part 42 contacts the secondary septal tissue.

[0118] In this regard, the relevant structures and concepts of the third embodiment are similar to those of the first embodiment, and thus will not be described again here.

[0119] The foregoing description of several embodiments of the present application has been presented for purposes of illustration. The foregoing description is not intended to be exhaustive nor to limit the present application to the precise configurations, structures, and / or steps disclosed. Obviously, many modifications and variations are possible in light of the above teachings. The scope of the invention and all equivalents are intended to be defined by the appended claims.

Claims

1. A closing device for achieving puncture by limiting tissue, used to close a passage between a first tissue and a second tissue, characterized in that: It includes a supporting unit, a supporting unit, a puncture unit and an auxiliary positioning unit, wherein the auxiliary positioning unit includes a positioning member and a control member connected to the positioning member, and the control member is connected to the distal end portion of the supporting unit; the supporting unit, the supporting unit and the auxiliary positioning unit jointly limit the relative position of the first tissue between the control member and the supporting unit.

2. The closing device for achieving puncture by limiting tissue according to claim 1, characterized in that: It also includes an auxiliary abutment mechanism. When the auxiliary abutment mechanism is operated, the angle formed between the control member and the support unit is reduced, and the clamping force exerted on the first tissue is increased.

3. The closing device for achieving puncture by limiting tissue according to claim 1, characterized in that: The auxiliary abutment mechanism includes a delivery tube, and the abutment unit is pre-installed in the delivery tube; and the abutment unit includes a moving part and a deformation part arranged at the distal end, a limiting structure is arranged at the distal end of the delivery tube, and the limiting structure provides a supporting force at the proximal end of the deformation part.

4. The closing device for achieving puncture by limiting tissue according to claim 1, characterized in that: The positioning member is a tubular member, and the entirety or proximal portion of the support unit can pass through the tubular cavity of the positioning member and achieve relative movement with the positioning member; and, the support unit adheres to the channel surface of the second tissue after being released; the control member passes through the through hole on the positioning member or the distal end of the positioning member and is connected to the abutment unit; and, the proximal end of the control member is a movable control, and the proximal end of the control member is pulled to change the position where the distal end of the abutment unit adheres to the first tissue.

5. The closing device for achieving puncture by limiting tissue according to claim 1, characterized in that: The puncture unit is pre-installed in the abutting unit; and the puncture unit directly unidirectionally passes through the first tissue and the second tissue during puncture; the overlapping area of ​​the first tissue and the second tissue is the puncture area of ​​the puncture needle.

6. The closing device for achieving puncture through limited tissue according to claim 1, characterized in that: The support unit includes a first support portion and a second support portion, which are a whole and respectively adhere to the channel surface of the first tissue and the channel surface of the second tissue; the first support portion includes a plurality of divergent first support members, and the second support portion includes a plurality of second support members with bent distal ends.

7. The closing device for achieving puncture through limited tissue according to claim 6, characterized in that: The abutment unit is connected to a bending control mechanism, and by operating the bending control mechanism, the distal end of the abutment unit rotates and / or swings toward the support unit until the distal end of the abutment unit abuts against the proximal surface of the first tissue, and the center line of the distal end of the abutment unit is perpendicular to or forms an obtuse angle with the surface of the first support portion.

8. The closing device for achieving puncture through limited tissue according to claim 3, characterized in that: The first tissue is secondary septal tissue, and the second tissue is primary septal tissue; after the distal end of the deformation portion contacts the secondary septal tissue, the moving portion continues to be pushed so that the deformation portion hits the right atrium wall to maintain the position of the deformation portion; or, the abutment unit is manipulated or the moving portion is pushed so that the deformation portion forms a deformation and bending transition state in the right atrial cavity, and the moving portion is continued to be pushed so that the distal end of the deformation portion contacts the secondary septal tissue.

9. The closing device for achieving puncture by limiting tissue according to claim 1, characterized in that: The control member is in the shape of a line, thread or rope, and the abutment unit includes a connection portion connected to the control member; and when the abutment unit is pushed to move toward the distal end, the connection portion moves with the control member to the proximal surface of the first tissue; a developing member is also provided on the connection portion.

10. The closing device for achieving puncture through limited tissue according to claim 1, characterized in that: The supporting unit is released before the abutting unit; Furthermore, after the support unit is released, the support unit is in contact with the first tissue and / or the second tissue.

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